This is a phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in non immunocompromised adult subjects with interdigital tinea pedis.
A phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in approximately 170 non immunocompromised adult subjects with interdigital tinea pedis. Subjects will apply the investigational product (IP) (SB208 or Vehicle Gel) to the interdigital areas and all affected and immediate surrounding areas of one or both feet once daily for 2 weeks, followed by a 4-week post-treatment observation period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
222
Instituto Dermatológico y Cirugía de Piel,
Santo Domingo, Dominican Republic
Fungal culture result
Negative fungal culture from target lesion
Time frame: 2 weeks
Clinical cure
Amelioration of signs and symptoms of tinea pedis
Time frame: 6 wks
Mycological cure
No evidence of fungal infection based on skin scraping and culture
Time frame: 6 wks
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Apply once daily to one or both feet for 14 days